K193473 is an FDA 510(k) clearance for the LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US. This device is classified as a Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) (Class II - Special Controls, product code MXD).
Submitted by Boston Scientific Corporation (St Paul, US). The FDA issued a Cleared decision on June 26, 2020, 193 days after receiving the submission on December 16, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K193473 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 2019 |
| Decision Date | June 26, 2020 |
| Days to Decision | 193 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MXD — Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1025 |